Atrix Manufacturing Cost definition

Atrix Manufacturing Cost means the actual cost of the Manufacture by Atrix of a Products under a Manufacturing Process, including the related quality assurance and quality control activities as required by Applicable Laws, which actual cost shall be comprised of the cost of goods produced as determined in accordance with GAAP, and shall include direct labor, direct material, including raw materials and packaging materials, and the allocable portion of the manufacturing overhead of Atrix directly attributable to the Manufacture of such Product. The allocable portion of the manufacturing overhead shall be determined by taking the total facility cost for the period, less an adjustment for idle capacity, and allocating the remaining facility cost by labor usage to each of the products produced in the facility during the period. For example: if the facility cost for the period was $1,000,000 and it was operating at 80% capacity, the allocable facility cost would be $800,000. If a Product represented 30% of labor usage during the period, the allocable portion of the manufacturing overhead directly attributable to the Manufacture of such Product would be $240,000. Atrix Manufacturing Cost shall exclude selling, general and administrative, research and development, and interest expenses and any and all debt service payments of Atrix.
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Atrix Manufacturing Cost means the actual cost of the Manufacture by Atrix of the Product under a Manufacturing Process, including the related quality assurance and quality control activities as required by Applicable Laws (other than the costs set forth in Section 2.03), which actual cost shall be comprised of the cost of goods produced as determined in accordance with GAAP, and shall include direct labor, direct material, including raw materials and packaging materials, and the allocable portion of the manufacturing overhead of Atrix directly attributable to the Manufacture of the Product. The allocable portion of the manufacturing overhead shall be determined by taking the total facility cost for the period, less an adjustment for idle capacity, and allocating the remaining facility cost by labor usage to each of the products produced in the facility during the period. For example: If the facility cost for the period was $1,000,000 and it was operating at 80% capacity, the allocable facility cost would be $800,000. If the Product represented 30% of labor usage during the period, the allocable portion of the manufacturing overhead directly attributable to the Manufacture of the Product would be $240,000. Atrix Manufacturing Cost shall exclude selling, general and administrative, research and development, and interest expenses and any and all debt service payments of Atrix. For a period of twelve (12) months from the date of First Commercial Sale of each Product the Atrix Manufacturing Cost for each Product will be set as follows (the "Twelve Month Cost"): One Month Product - [**] Three Month Product - [**] Four Month Product - [**]
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Atrix Manufacturing Cost means the actual cost of the Manufacture by Atrix of a Products under a Manufacturing Process, including the related quality assurance and quality control activities as required by Applicable Laws, which actual cost shall be comprised of the cost of goods produced as determined in accordance with GAAP, and shall include direct labor, direct material, including raw materials and packaging materials, and the allocable portion of the manufacturing overhead of Atrix directly attributable to the Manufacture of such Product. The allocable portion of the manufacturing overhead shall be determined by taking the total facility cost for the period, less an adjustment for idle capacity, and allocating the remaining facility cost by labor usage to each of the products produced in the facility during the period. For example: if the facility cost for the period was $1,000,000 and it was operating at 80% capacity, the allocable facility cost would be $800,000. If a Product represented 30% of labor usage during the period,
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Examples of Atrix Manufacturing Cost in a sentence

  • Demonstration Samples shall be sold by Atrix to Sanofi-Synthelabo at the Atrix Manufacturing Cost for such Demonstration Samples.

  • Sanofi-Synthelabo may terminate this Agreement prior to the expiration of the Term with respect to any country in the Territory upon an increase in the Atrix Manufacturing Cost over the Twelve Month Cost and the failure of Sanofi-Synthelabo and Atrix to reach mutual agreement on the Purchase Price of the Product.

  • Atrix shall sell, and Sanofi-Synthelabo shall purchase, each Product at a price equal to the Atrix Manufacturing Cost, including any adjustments pursuant to Section 8.02 (the "Purchase Price").

  • During the Term and for a period of three (3) years thereafter, Geneva and Atrix shall keep complete and accurate records in sufficient detail to permit Atrix or Geneva, as the case may be, to confirm the accuracy of all payments due hereunder (including the calculation of Atrix Manufacturing Cost, Gross Sales, Net Sales and Selling Expenses).

  • Each payment shall be accompanied by a report in sufficient detail to permit confirmation of the accuracy of the payment made, including, without limitation, Gross Sales and Net Sales detailed country by country in the Territory, Selling Expenses, the Atrix Manufacturing Cost, the method used to calculate the payment and the exchange rates used, if any.

  • Geneva shall pay to Atrix its share of research and development expenses under Section 3.02 (which expenses are in excess of the Retainer payments received by Atrix for such Product as determined in accordance with Section 3.03) and the Atrix Manufacturing Cost under Section 7.01, within thirty (30) days following receipt of the applicable monthly invoice.


More Definitions of Atrix Manufacturing Cost

Atrix Manufacturing Cost means the actual cost of Manufacture by Atrix of a Product under a Manufacturing Process, which actual cost shall be comprised of the cost of goods produced as determined in accordance with GAAP, and shall include direct labor, direct material, including raw materials and packaging materials, and the allocable portion of the manufacturing overhead of Atrix directly attributable to the manufacture of a Product, determined by taking the total output of such Product during the period divided by the total output of all products manufactured by Atrix during the period, multiplied by the total amount of manufacturing overhead for the period. Atrix Manufacturing Cost shall exclude selling, general and administrative, research and development, and interest expenses and any and all debt service payments of Atrix. The Atrix Manufacturing Cost shall include, to the extent applicable, the cost to Atrix of having some portion or all of the Manufacturing Process performed by a Third Party; but shall exclude any incremental increases in the Atrix Manufacturing Costs resulting from the use of a toll manufacturer under Sections 6.01 or 6.04 of this Agreement. Sixty (60) days prior to the First Commercial Sale of a Product, Atrix shall provide Geneva a written estimate of the Atrix Manufacturing Cost for such Product for purposes of calculating Net Profits and Atrix Profit Share for the first calendar year in which the First Commercial Sale occurs. For each subsequent calendar year, the Atrix Manufacturing Cost used to calculate the Net Profits and Atrix Profit Share for that calendar year shall equal the actual Atrix Manufacturing Cost for such Product for the preceding calendar year (as determined in accordance with Section 7.02(c)).
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Atrix Manufacturing Cost means the actual cost of the Manufacture of the Product by Atrix (including any subcontractor and Second Source) during each calendar year during the Term, including the related quality assurance and quality control activities as required by Applicable Laws, which actual cost shall be determined in accordance with GAAP, and shall include direct labor, direct material (including Raw Materials and Components), direct overhead (e.g. depreciation of a packaging line solely dedicated to the Product) and the allocable portion -------- ** Confidential Treatment Requested 2 of the direct and indirect Manufacturing overhead directly attributable to the Manufacture of the Product. The allocable portion of the manufacturing overhead shall be determined by [ ]** The manufacturing overhead shall be allocated to the Product utilizing an appropriate [ ]** Atrix Manufacturing Cost shall exclude selling, general and administrative, research and development, interest expenses, any and all debt service payments of Atrix, and any other costs not directly associated with the Manufacture of the Product, other than direct and indirect manufacturing overhead. The Parties agree that in no event shall Atrix Manufacturing Cost include capital expenditures and improvements to or for Atrix's manufacturing facility(ies) or those of the Second Source or any approved subcontractor, except as directly or indirectly allocated through Manufacturing overhead. If any part of the Manufacturing is conducted by an approved subcontractor, any Manufacturing costs incurred by such subcontractor and passed on to FHI shall not exceed [ ]** of the Atrix Manufacturing Costs that would have been incurred by Atrix if Atrix had conducted such part of the Manufacturing.
Sample 1

Related to Atrix Manufacturing Cost

  • Manufacturing Cost means ***

  • Manufacturing Costs means, with respect to a given AquaBounty Product, the full-time equivalent costs (under a reasonable accounting mechanism to be agreed upon by the Parties) and out-of-pocket costs that AquaBounty or any of its Affiliates incurred in manufacturing such products, including costs and expenses incurred in connection with (a) the development or validation of any manufacturing process, formulations or delivery systems, or improvements to the foregoing; (b) manufacturing scale-up; (c) in-process testing, stability testing and release testing; (d) quality assurance/quality control development; (e) internal and Third Party costs and expenses incurred in connection with qualification and validation of Third Party contract manufacturers, including scale up, process and equipment validation, and initial manufacturing licenses, approvals and inspections; (f) packaging development and final packaging and labeling; (g) shipping configurations and shipping studies; and (h) overseeing the conduct of any of the foregoing. “Manufacturing Costs” shall further include: (i) to the extent that any such AquaBounty Product is manufactured by a Third Party manufacturer, the out-of-pocket costs incurred by AquaBounty or any of its Affiliates to the Third Party for the manufacture and supply (including packaging and labeling) thereof, and any reasonable out-of-pocket costs and direct labor costs incurred by AquaBounty or any of its Affiliates in managing or overseeing the Third Party relationship determined in accordance with the books and records of such Party or its Affiliates maintained in accordance with US GAAP; and (ii) to the extent that any such AquaBounty Product is manufactured by AquaBounty or any of its Affiliates, direct material and direct labor costs attributable to such product, as well as reasonably allocable overhead expenses, determined in accordance with the books and records of AquaBounty or its Affiliates maintained in accordance with US GAAP.

  • Fully Burdened Manufacturing Cost means, with respect to any Licensed Product supplied by or on behalf of NVCR to Zai hereunder if such Licensed Product (or any precursor or intermediate thereof) is manufactured by a Third Party manufacturer [***].

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • Development Cost means the total of all costs incurred in the completion of a Development excluding Developer Fee, operating deficit reserves, and total land cost as typically shown in the Development Cost line item on the development cost pro forma.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • COGS means the cost of goods sold as determined in accordance with U.S.GAAP;

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, as set forth in this Agreement, required to manufacture Product or Products using the Active Materials, Components, and Xxxx Back Items;

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

  • API means the American Petroleum Institute.

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Current Good Manufacturing Practices or “cGMP” means applicable Good Manufacturing Practices as specified in the United States Code of Federal Regulations and/or the EU Good Manufacturing Guidelines, and any successor legislation from time to time, prevailing at the time of the manufacture of the Product.

  • Manufacturing Facilities means facilities engaged in the mechanical or chemical transformation of materials or substances into new products and shall include:

  • Finished Products means any one or more of the following petroleum oils, or a mixture or combination of these oils, to be used without further processing except blending by mechanical means:

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.

  • Development Costs means costs incurred to obtain access to reserves and to provide facilities for extracting, treating, gathering and storing the oil and gas from reserves. More specifically, development costs, including applicable operating costs of support equipment and facilities and other costs of development activities, are costs incurred to:

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • Routine Patient Costs means all health care services that are otherwise covered under the Group Contract for the treatment of cancer or other Life-threatening Condition that is typically covered for a patient who is not enrolled in an Approved Clinical Trial.

  • Manufacturing Technology means any and all patents, patent applications, know-how, and all intellectual property rights associated therewith that are owned or controlled by Licensor, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno-associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Final Product means a reasonably homogenous cannabis product in its final packaged form created using the same standard operating procedures and the same formulation.